Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedVadis Research Corporation
ClinicalTrials.gov Identifier:
NCT00963040
First received: August 18, 2009
Last updated: September 8, 2011
Last verified: September 2011

August 18, 2009
September 8, 2011
November 2009
August 2010   (final data collection date for primary outcome measure)
Reduction in headache intensity [ Time Frame: 2 hours post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00963040 on ClinicalTrials.gov Archive Site
Reduction in nausea, vomiting, photophobia, and phonophobia [ Time Frame: 2 hours post-treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
The Effect of Intranasal Oxytocin on Headache Intensity and Headache-associated Symptoms in Patients Suffering From Chronic Daily Headache

The objective of this prospective, randomized, double-blind, parallel-group, placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects suffering from chronic daily headache. The primary outcome measure is the reduction in headache intensity after drug administration; secondary outcome measures are the headache symptoms, nausea, vomiting, photophobia, and phonophobia. Additional secondary outcome measures are intake of rescue medication and patient satisfaction over a period of 24 hours.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Daily Headache
  • Drug: Syntocinon (Oxytocin)
    4 actuations in each nostril for a total dose of 32 IU
  • Drug: Sterile water
    4 actuations in each nostril
  • Experimental: Syntocinon®
    Intervention: Drug: Syntocinon (Oxytocin)
  • Placebo Comparator: Sterile water
    Intervention: Drug: Sterile water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
  2. More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale.
  3. Headaches typically last for at least 4 hours.
  4. Subjects are on a stable headache treatment, if any, for at least 2 months.

Exclusion Criteria:

  1. Headache symptoms assessed to be predominately occipital.
  2. Allergy to oxytocin.
  3. History of addictive behavior (e.g. alcoholism, drug abuse).
  4. History of significant psychiatric disorder.
  5. History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
  6. Upper-respiratory tract infection at the time of randomization.
  7. Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
  8. Nasal obstruction of any cause as determined at screening.
  9. Major surgery or trauma within 4 weeks of screening.
  10. Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
  11. Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
  12. Use of an investigational medication or device within 30 days of randomization.
  13. Unable or unwilling to adhere to the study-specific procedures and restrictions.
  14. Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
  15. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
  16. Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00963040
TI-004
No
MedVadis Research Corporation
MedVadis Research Corporation
Not Provided
Principal Investigator: Egilius LH Spierings, MD, PhD Harvard Medical School
MedVadis Research Corporation
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP